Regulatory Information and Guidance on Biosimilars and Their Use Across Europe: A Call for Strengthened One Voice Messaging

BACKGROUND: Beyond evaluation and approval, European and national regulators have a key role in providing reliable information on biosimilars and the science underpinning their development, approval, and use. OBJECTIVES: This study aims to (i) review biosimilar information and guidance provided by E...

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Detalles Bibliográficos
Autores principales: Barbier, Liese, Mbuaki, Allary, Simoens, Steven, Declerck, Paul, Vulto, Arnold G., Huys, Isabelle
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Medicine
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8959407/
https://www.ncbi.nlm.nih.gov/pubmed/35355594
http://dx.doi.org/10.3389/fmed.2022.820755

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8959407/
https://www.ncbi.nlm.nih.gov/pubmed/35355594
http://dx.doi.org/10.3389/fmed.2022.820755

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